Registration Dossier
Registration Dossier
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EC number: 617-116-8 | CAS number: 80573-04-2
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline is specified in the report.
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Cas Number:
- 150399-21-6
- Molecular formula:
- C17H13N3O6Na2 . 2H2O
- IUPAC Name:
- Benzoic acid, 5-[(1E)-[4-[[(2-carboxyethyl)amino]carbonyl]phenyl]azo]-2- hydroxy-, disodium salt, dihydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Biorex
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 3, 12 and 27 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- 5 male animals per dose were used for the fertility test after 3, 12 and 27 weeks of treatment.
- Control animals:
- yes, plain diet
- Details on study design:
- The test was performed by mating each male with 5 females of proven fertility for 4 days then females were killed 14 days later.
Examinations
- Postmortem examinations (parental animals):
- SACRIFICE
- Maternal animals: All females were sacrificed 14 days after mating.
GROSS NECROPSY
- The number of pregnant females, corpora lutea, live/ dead foetuses and early/ late resorptions were recorded.
Results and discussion
Results: P0 (first parental generation)
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- Male fertility was not affected by the treatment
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- reproductive performance
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
For general toxicity results, please refer to IUCLID Section 7.5.1 (96 week study).
Applicant's summary and conclusion
- Conclusions:
- No treatment related effects on male fertility were observed up to the highest dose tested.
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